44 | | - | LC001940/SUB A/2 - Page 2 of 15 |
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45 | | - | 27-18-92. Expedited Prior Authorization. 1 |
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46 | | - | To the extent a prior authorization is permitted and applied, then it shall be conducted in 2 |
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47 | | - | an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant to § 27-3 |
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48 | | - | 18.9-6(a)(1). 4 |
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49 | | - | 27-18-93. Dispensing and Administration of HIV PrEP or PEP Drugs. 5 |
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50 | | - | (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 6 |
---|
51 | | - | Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 7 |
---|
52 | | - | subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 8 |
---|
53 | | - | PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 9 |
---|
54 | | - | pursuant to a standing order or collaborative practice agreement or to protocols developed by the 10 |
---|
55 | | - | board for when there is no prescription drug order, standing order or collaborative practice 11 |
---|
56 | | - | agreement in accordance with the requirements in this subsection and may also order laboratory 12 |
---|
57 | | - | testing for HIV infection as necessary. 13 |
---|
58 | | - | (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 14 |
---|
59 | | - | training program approved by the board on the use of protocols developed by the board for 15 |
---|
60 | | - | prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 16 |
---|
61 | | - | laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 17 |
---|
62 | | - | to counsel patients prescribed an HIV prevention drug. 18 |
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63 | | - | (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 19 |
---|
64 | | - | day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 20 |
---|
65 | | - | (1) The patient tests negative for HIV infection, as documented by a negative HIV test 21 |
---|
66 | | - | result obtained within the previous seven (7) days. If the patient does not provide evidence of a 22 |
---|
67 | | - | negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 23 |
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68 | | - | directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 24 |
---|
69 | | - | If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 25 |
---|
70 | | - | direct the patient to a primary care provider and provide a list of primary care providers and clinics 26 |
---|
71 | | - | within a reasonable travel distance of the patient's residence; 27 |
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72 | | - | (2) The patient does not report any signs or symptoms of acute HIV infection on a self-28 |
---|
73 | | - | reporting checklist of acute HIV infection signs and symptoms; 29 |
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74 | | - | (3) The patient does not report taking any contraindicated medications; 30 |
---|
75 | | - | (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 31 |
---|
76 | | - | the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 32 |
---|
77 | | - | be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 33 |
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78 | | - | that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 34 |
---|
| 44 | + | LC001940 - Page 2 of 8 |
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| 45 | + | standards, or other factors used in applying the limitation with respect to medical/surgical benefits 1 |
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| 46 | + | in the classification. 2 |
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| 47 | + | (e) The following classifications shall be used to apply the coverage requirements of this 3 |
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| 48 | + | chapter: 4 |
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| 49 | + | (1) Inpatient, in-network; 5 |
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| 50 | + | (2) Inpatient, out-of-network; 6 |
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| 51 | + | (3) Outpatient, in-network; 7 |
---|
| 52 | + | (4) Outpatient, out-of-network; 8 |
---|
| 53 | + | (5) Emergency care; and 9 |
---|
| 54 | + | (6) Prescription drugs. 10 |
---|
| 55 | + | (f) Payors shall rely upon the criteria of the Society of Infectious Diseases Pharmacists 11 |
---|
| 56 | + | when developing coverage for levels of care for HIV prevention treatment. 12 |
---|
| 57 | + | 27-38.3-2. Definitions. 13 |
---|
| 58 | + | As used in this section, unless the context otherwise indicates, the following terms have 14 |
---|
| 59 | + | the following meanings: 15 |
---|
| 60 | + | (1) "CDC guidelines" means guidelines related to the nonoccupational exposure to 16 |
---|
| 61 | + | potential HIV infection, or any subsequent guidelines, published by the federal Department of 17 |
---|
| 62 | + | Health and Human Services, Centers for Disease Control and Prevention. 18 |
---|
| 63 | + | (2) "Financial requirements" means deductibles, copayments, coinsurance, or out-of-19 |
---|
| 64 | + | pocket maximums. 20 |
---|
| 65 | + | (3) "Group health plan" means an employee welfare benefit plan as defined in 29 U.S.C. § 21 |
---|
| 66 | + | 1002(1) to the extent that the plan provides health benefits to employees or their dependents directly 22 |
---|
| 67 | + | or through insurance, reimbursement, or otherwise. For purposes of this chapter, a group health 23 |
---|
| 68 | + | plan shall not include a plan that provides health benefits directly to employees or their dependents, 24 |
---|
| 69 | + | except in the case of a plan provided by the state or an instrumentality of the state. 25 |
---|
| 70 | + | (4) "Health insurance plan" means health insurance coverage offered, delivered, issued for 26 |
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| 71 | + | delivery, or renewed by a health insurer. 27 |
---|
| 72 | + | (5) "Health insurers" means all persons, firms, corporations, or other organizations offering 28 |
---|
| 73 | + | and assuring health services on a prepaid or primarily expense-incurred basis, including, but not 29 |
---|
| 74 | + | limited to, policies of accident or sickness insurance, as defined by chapter 18 of this title; nonprofit 30 |
---|
| 75 | + | hospital or medical service plans, whether organized under chapter 19 or 20 of this title or under 31 |
---|
| 76 | + | any public law or by special act of the general assembly; health maintenance organizations, or any 32 |
---|
| 77 | + | other entity that insures or reimburses for diagnostic, therapeutic, or preventive services to a 33 |
---|
| 78 | + | determined population on the basis of a periodic premium. Provided, this chapter does not apply to 34 |
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81 | | - | LC001940/SUB A/2 - Page 3 of 15 |
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82 | | - | PEP drug to a single patient once every two (2) years without a prescription; 1 |
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83 | | - | (5) The pharmacist documents, to the extent possible, the services provided by the 2 |
---|
84 | | - | pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 3 |
---|
85 | | - | The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 4 |
---|
86 | | - | patient; 5 |
---|
87 | | - | (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 6 |
---|
88 | | - | PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 7 |
---|
89 | | - | practitioner; and 8 |
---|
90 | | - | (7) The pharmacist notifies the patient's primary care provider that the pharmacist 9 |
---|
91 | | - | completed the requirements specified in this subsection. If the patient does not have a primary care 10 |
---|
92 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 11 |
---|
93 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 12 |
---|
94 | | - | follow-up care. 13 |
---|
95 | | - | (d) A pharmacist shall dispense or administer a complete course of a post-exposure 14 |
---|
96 | | - | prophylaxis drug as long as all of the following conditions are met: 15 |
---|
97 | | - | (1) The pharmacist screens the patient and determines that the exposure occurred within 16 |
---|
98 | | - | the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 17 |
---|
99 | | - | exposure prophylaxis drug under CDC guidelines; 18 |
---|
100 | | - | (2) The pharmacist provides HIV testing to the patient or determines that the patient is 19 |
---|
101 | | - | willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 20 |
---|
102 | | - | HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 21 |
---|
103 | | - | the pharmacist may dispense or administer a post-exposure prophylaxis drug; 22 |
---|
104 | | - | (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 23 |
---|
105 | | - | the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 24 |
---|
106 | | - | availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 25 |
---|
107 | | - | (4) The pharmacist notifies the patient's primary care provider of the dispensing or 26 |
---|
108 | | - | administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 27 |
---|
109 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 28 |
---|
110 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 29 |
---|
111 | | - | follow-up care. 30 |
---|
112 | | - | (e) The board shall promulgate rules and regulations establishing standards for authorizing 31 |
---|
113 | | - | pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 32 |
---|
114 | | - | section, including adequate training requirements and protocols for when there is no prescription 33 |
---|
115 | | - | drug order, standing order or collaborative practice agreement. 34 |
---|
| 81 | + | LC001940 - Page 3 of 8 |
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| 82 | + | insurance coverage providing benefits for: 1 |
---|
| 83 | + | (i) Hospital confinement indemnity; 2 |
---|
| 84 | + | (ii) Disability income; 3 |
---|
| 85 | + | (iii) Accident only; 4 |
---|
| 86 | + | (iv) Long-term care; 5 |
---|
| 87 | + | (v) Medicare supplement; 6 |
---|
| 88 | + | (vi) Limited benefit health; 7 |
---|
| 89 | + | (vii) Specific disease indemnity; 8 |
---|
| 90 | + | (viii) Sickness or bodily injury or death by accident or both; and 9 |
---|
| 91 | + | (ix) Other limited benefit policies. 10 |
---|
| 92 | + | (6) "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 11 |
---|
| 93 | + | prophylaxis drug or other drug approved for the prevention of HIV infection by the federal Food 12 |
---|
| 94 | + | and Drug Administration. 13 |
---|
| 95 | + | (7) "Non-quantitative treatment limitations" means: 14 |
---|
| 96 | + | (i) Medical management standards; 15 |
---|
| 97 | + | (ii) Formulary design and protocols; 16 |
---|
| 98 | + | (iii) Network tier design; 17 |
---|
| 99 | + | (iv) Standards for provider admission to participate in a network; 18 |
---|
| 100 | + | (v) Reimbursement rates and methods for determining usual, customary, and reasonable 19 |
---|
| 101 | + | charges; and 20 |
---|
| 102 | + | (vi) Other criteria that limit scope or duration of coverage for services in the prevention 21 |
---|
| 103 | + | treatment of HIV infection, including restrictions based on geographic location, facility type, and 22 |
---|
| 104 | + | provider specialty. 23 |
---|
| 105 | + | (8) "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 24 |
---|
| 106 | + | clinical eligibility recommendations provided in CDC guidelines following potential exposure to 25 |
---|
| 107 | + | HIV infection. 26 |
---|
| 108 | + | (9) "Preexposure prophylaxis drug" means a drug or drug combination that meets the 27 |
---|
| 109 | + | clinical eligibility recommendations provided in CDC guidelines to prevent HIV infection. 28 |
---|
| 110 | + | (10) "Quantitative treatment limitations" means numerical limits on coverage for the 29 |
---|
| 111 | + | preventive treatment of HIV infection based on the frequency of treatment, number of visits, days 30 |
---|
| 112 | + | of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. 31 |
---|
| 113 | + | 27-38.3-3. Coverage required. 32 |
---|
| 114 | + | A health insurer offering a health plan in this state shall provide coverage for an HIV 33 |
---|
| 115 | + | prevention drug that has been prescribed by a provider. Coverage under this section is subject to 34 |
---|
118 | | - | LC001940/SUB A/2 - Page 4 of 15 |
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119 | | - | SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service 1 |
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120 | | - | Corporations" is hereby amended by adding thereto the following sections: 2 |
---|
121 | | - | 27-19-83. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 3 |
---|
122 | | - | prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 4 |
---|
123 | | - | (a) Every group health insurance contract, or every group hospital or medical expense 5 |
---|
124 | | - | insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 6 |
---|
125 | | - | any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 7 |
---|
126 | | - | pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 8 |
---|
127 | | - | (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 9 |
---|
128 | | - | constitute a separate method of administration. A health insurer is not required to cover any 10 |
---|
129 | | - | preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 11 |
---|
130 | | - | out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 12 |
---|
131 | | - | pharmacy benefit. 13 |
---|
132 | | - | (b) The healthcare benefits outlined in this chapter apply only to services delivered within 14 |
---|
133 | | - | the health insurer’s provider network; provided that, all health insurers shall be required to provide 15 |
---|
134 | | - | coverage for those benefits mandated by this chapter outside of the health insurer’s provider 16 |
---|
135 | | - | network where it can be established that the required services are not available from a provider in 17 |
---|
136 | | - | the health insurer’s network. 18 |
---|
137 | | - | 27-19-84. Expedited Prior Authorization. 19 |
---|
138 | | - | To the extent a prior authorization is permitted and applied, then it shall be conducted in 20 |
---|
139 | | - | an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant to § 27-21 |
---|
140 | | - | 18.9-6(a)(1). 22 |
---|
141 | | - | 27-19-85. Dispensing and Administration of HIV PrEP or PEP Drugs. 23 |
---|
142 | | - | (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 24 |
---|
143 | | - | Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 25 |
---|
144 | | - | subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 26 |
---|
145 | | - | PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 27 |
---|
146 | | - | pursuant to a standing order or collaborative practice agreement or to protocols developed by the 28 |
---|
147 | | - | board for when there is no prescription drug order, standing order or collaborative practice 29 |
---|
148 | | - | agreement in accordance with the requirements in this subsection and may also order laboratory 30 |
---|
149 | | - | testing for HIV infection as necessary. 31 |
---|
150 | | - | (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 32 |
---|
151 | | - | training program approved by the board on the use of protocols developed by the board for 33 |
---|
152 | | - | prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 34 |
---|
| 118 | + | LC001940 - Page 4 of 8 |
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| 119 | + | the following; 1 |
---|
| 120 | + | (1) If the federal Food and Drug Administration has approved one or more HIV prevention 2 |
---|
| 121 | + | drugs that use the same method of administration, a health insurer is not required to cover all 3 |
---|
| 122 | + | approved drugs as long as the insurer covers at least one approved drug for each method of 4 |
---|
| 123 | + | administration with no out-of-pocket cost. 5 |
---|
| 124 | + | (2) A health insurer is not required to cover any preexposure prophylaxis drug or post-6 |
---|
| 125 | + | exposure prophylaxis drug dispensed or administered by an out-of-network pharmacy provider 7 |
---|
| 126 | + | unless the enrollee's health plan provides an out-of-network pharmacy benefit. 8 |
---|
| 127 | + | (3) A health insurer shall not prohibit or permit a pharmacy benefits manager to prohibit a 9 |
---|
| 128 | + | pharmacy provider from dispensing or administering any HIV prevention drugs. 10 |
---|
| 129 | + | 27-38.3-4. Limits on prior authorization and step therapy requirements. 11 |
---|
| 130 | + | Notwithstanding any requirements to the contrary, a health insurer shall not subject any 12 |
---|
| 131 | + | HIV prevention drug to any prior authorization or step therapy requirement except as provided in 13 |
---|
| 132 | + | this section. If the federal Food and Drug Administration has approved one or more methods of 14 |
---|
| 133 | + | administering HIV prevention drugs, an insurer is not required to cover all of the approved drugs 15 |
---|
| 134 | + | without prior authorization or step therapy requirements as long as the insurer covers at least one 16 |
---|
| 135 | + | approved drug for each method of administration without prior authorization or step therapy 17 |
---|
| 136 | + | requirements. If prior authorization or step therapy requirements are met for a particular enrollee 18 |
---|
| 137 | + | with regard to a particular HIV prevention drug, the insurer is required to cover that drug with no 19 |
---|
| 138 | + | out-of-pocket cost to the enrollee. 20 |
---|
| 139 | + | 27-38.3-5. Coverage for laboratory testing related to HIV prevention drugs. 21 |
---|
| 140 | + | A health insurer offering a health plan in this state shall provide coverage with no out-of-22 |
---|
| 141 | + | pocket cost for laboratory testing recommended by a provider related to the ongoing monitoring of 23 |
---|
| 142 | + | an enrollee who is taking an HIV prevention drug covered by this chapter. 24 |
---|
| 143 | + | 27-38.3-6. Medical necessity and appropriateness of treatment. 25 |
---|
| 144 | + | (a) Upon request of the reimbursing health insurers, all providers of prevention treatment 26 |
---|
| 145 | + | of HIV infection shall furnish medical records or other necessary data which substantiates that 27 |
---|
| 146 | + | initial or continued treatment is at all times medically necessary and/or appropriate. When the 28 |
---|
| 147 | + | provider cannot establish the medical necessity and/or appropriateness of the treatment modality 29 |
---|
| 148 | + | being provided, neither the health insurer nor the patient shall be obligated to reimburse for that 30 |
---|
| 149 | + | period or type of care that was not established. Exception to the preceding requirement can only be 31 |
---|
| 150 | + | made if the patient has been informed of the provisions of this subsection and has agreed in writing 32 |
---|
| 151 | + | to continue to receive treatment at their own expense. 33 |
---|
| 152 | + | (b) The health insurers, when making the determination of medically necessary and 34 |
---|
155 | | - | LC001940/SUB A/2 - Page 5 of 15 |
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156 | | - | laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 1 |
---|
157 | | - | to counsel patients prescribed an HIV prevention drug. 2 |
---|
158 | | - | (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 3 |
---|
159 | | - | day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 4 |
---|
160 | | - | (1) The patient tests negative for HIV infection, as documented by a negative HIV test 5 |
---|
161 | | - | result obtained within the previous seven (7) days. If the patient does not provide evidence of a 6 |
---|
162 | | - | negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 7 |
---|
163 | | - | directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 8 |
---|
164 | | - | If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 9 |
---|
165 | | - | direct the patient to a primary care provider and provide a list of primary care providers and clinics 10 |
---|
166 | | - | within a reasonable travel distance of the patient's residence; 11 |
---|
167 | | - | (2) The patient does not report any signs or symptoms of acute HIV infection on a self-12 |
---|
168 | | - | reporting checklist of acute HIV infection signs and symptoms; 13 |
---|
169 | | - | (3) The patient does not report taking any contraindicated medications; 14 |
---|
170 | | - | (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 15 |
---|
171 | | - | the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 16 |
---|
172 | | - | be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 17 |
---|
173 | | - | that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 18 |
---|
174 | | - | PEP drug to a single patient once every two (2) years without a prescription; 19 |
---|
175 | | - | (5) The pharmacist documents, to the extent possible, the services provided by the 20 |
---|
176 | | - | pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 21 |
---|
177 | | - | The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 22 |
---|
178 | | - | patient; 23 |
---|
179 | | - | (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 24 |
---|
180 | | - | PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 25 |
---|
181 | | - | practitioner; and 26 |
---|
182 | | - | (7) The pharmacist notifies the patient's primary care provider that the pharmacist 27 |
---|
183 | | - | completed the requirements specified in this subsection. If the patient does not have a primary care 28 |
---|
184 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 29 |
---|
185 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 30 |
---|
186 | | - | follow-up care. 31 |
---|
187 | | - | (d) A pharmacist shall dispense or administer a complete course of a post-exposure 32 |
---|
188 | | - | prophylaxis drug as long as all of the following conditions are met: 33 |
---|
189 | | - | (1) The pharmacist screens the patient and determines that the exposure occurred within 34 |
---|
| 155 | + | LC001940 - Page 5 of 8 |
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| 156 | + | appropriate treatment, shall do so in a manner consistent with that used to make the determination 1 |
---|
| 157 | + | for the treatment of other diseases or injuries covered under the health insurance policy or 2 |
---|
| 158 | + | agreement. 3 |
---|
| 159 | + | (c) Any subscriber who is aggrieved by a denial of benefits provided under this chapter 4 |
---|
| 160 | + | may appeal a denial in accordance with the rules and regulations promulgated by the department 5 |
---|
| 161 | + | of health pursuant to chapter 17.12 of title 23. 6 |
---|
| 162 | + | 27-38.3-7. Network coverage. 7 |
---|
| 163 | + | The healthcare benefits outlined in this chapter apply only to services delivered within the 8 |
---|
| 164 | + | health insurer’s provider network; provided that, all health insurers shall be required to provide 9 |
---|
| 165 | + | coverage for those benefits mandated by this chapter outside of the health insurer’s provider 10 |
---|
| 166 | + | network where it can be established that the required services are not available from a provider in 11 |
---|
| 167 | + | the health insurer’s network. 12 |
---|
| 168 | + | SECTION 2. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended 13 |
---|
| 169 | + | by adding thereto the following section: 14 |
---|
| 170 | + | 5-19.1-31.1. Prescribing, dispensing and administering HIV prevention drugs. 15 |
---|
| 171 | + | (a) Definitions. As used in this section, unless the context otherwise indicates, the 16 |
---|
| 172 | + | following terms have the following meanings. 17 |
---|
| 173 | + | (1) "CDC guidelines" means guidelines related to nonoccupational exposure to potential 18 |
---|
| 174 | + | HIV infection, or any subsequent guidelines, published by the federal Department of Health and 19 |
---|
| 175 | + | Human Services, Centers for Disease Control and Prevention. 20 |
---|
| 176 | + | (2) "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 21 |
---|
| 177 | + | prophylaxis drug or other drug approved for the prevention of HIV infection by the federal Food 22 |
---|
| 178 | + | and Drug Administration. 23 |
---|
| 179 | + | (3) "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 24 |
---|
| 180 | + | clinical eligibility recommendations provided in CDC guidelines following potential exposure to 25 |
---|
| 181 | + | HIV infection. 26 |
---|
| 182 | + | (4) "Preexposure prophylaxis drug" means a drug or drug combination that meets the 27 |
---|
| 183 | + | clinical eligibility recommendations provided in CDC guidelines to prevent HIV infection. 28 |
---|
| 184 | + | (b) Authorization. Notwithstanding any provision of law to the contrary and as authorized 29 |
---|
| 185 | + | by the board in accordance with rules and regulations adopted under subsection (c) of this section, 30 |
---|
| 186 | + | a pharmacist may prescribe, dispense and administer HIV prevention drugs pursuant to a standing 31 |
---|
| 187 | + | order or collaborative practice agreement or to protocols developed by the board for when there is 32 |
---|
| 188 | + | no prescription drug order, standing order or collaborative practice agreement in accordance with 33 |
---|
| 189 | + | the requirements in this subsection and may also order laboratory testing for HIV infection as 34 |
---|
192 | | - | LC001940/SUB A/2 - Page 6 of 15 |
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193 | | - | the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 1 |
---|
194 | | - | exposure prophylaxis drug under CDC guidelines; 2 |
---|
195 | | - | (2) The pharmacist provides HIV testing to the patient or determines that the patient is 3 |
---|
196 | | - | willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 4 |
---|
197 | | - | HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 5 |
---|
198 | | - | the pharmacist may dispense or administer a post-exposure prophylaxis drug; 6 |
---|
199 | | - | (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 7 |
---|
200 | | - | the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 8 |
---|
201 | | - | availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 9 |
---|
202 | | - | (4) The pharmacist notifies the patient's primary care provider of the dispensing or 10 |
---|
203 | | - | administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 11 |
---|
204 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 12 |
---|
205 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 13 |
---|
206 | | - | follow-up care. 14 |
---|
207 | | - | (e) The board shall promulgate rules and regulations establishing standards for authorizing 15 |
---|
208 | | - | pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 16 |
---|
209 | | - | section, including adequate training requirements and protocols for when there is no prescription 17 |
---|
210 | | - | drug order, standing order or collaborative practice agreement. 18 |
---|
211 | | - | SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service 19 |
---|
212 | | - | Corporations" is hereby amended by adding thereto the following sections: 20 |
---|
213 | | - | 27-20-79. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 21 |
---|
214 | | - | prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 22 |
---|
215 | | - | (a) Every group health insurance contract, or every group hospital or medical expense 23 |
---|
216 | | - | insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 24 |
---|
217 | | - | any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 25 |
---|
218 | | - | pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 26 |
---|
219 | | - | (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 27 |
---|
220 | | - | constitute a separate method of administration. A health insurer is not required to cover any 28 |
---|
221 | | - | preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 29 |
---|
222 | | - | out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 30 |
---|
223 | | - | pharmacy benefit. 31 |
---|
224 | | - | (b) The healthcare benefits outlined in this chapter apply only to services delivered within 32 |
---|
225 | | - | the health insurer’s provider network; provided that, all health insurers shall be required to provide 33 |
---|
226 | | - | coverage for those benefits mandated by this chapter outside of the health insurer’s provider 34 |
---|
| 192 | + | LC001940 - Page 6 of 8 |
---|
| 193 | + | necessary. 1 |
---|
| 194 | + | (i) Before furnishing an HIV prevention drug to a patient, a pharmacist shall complete a 2 |
---|
| 195 | + | training program approved by the board on the use of protocols developed by the board for 3 |
---|
| 196 | + | prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 4 |
---|
| 197 | + | laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 5 |
---|
| 198 | + | to counsel patients prescribed an HIV prevention drug. 6 |
---|
| 199 | + | (ii) A pharmacist shall dispense or administer a preexposure prophylaxis drug in at least a 7 |
---|
| 200 | + | thirty (30) day supply, and up to a sixty (60) day supply, as long as all of the following conditions 8 |
---|
| 201 | + | are met: 9 |
---|
| 202 | + | (A) The patient tests negative for HIV infection, as documented by a negative HIV test 10 |
---|
| 203 | + | result obtained within the previous seven (7) days. If the patient does not provide evidence of a 11 |
---|
| 204 | + | negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 12 |
---|
| 205 | + | directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 13 |
---|
| 206 | + | If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 14 |
---|
| 207 | + | direct the patient to a primary care provider and provide a list of primary care providers and clinics 15 |
---|
| 208 | + | within a reasonable travel distance of the patient's residence; 16 |
---|
| 209 | + | (B) The patient does not report any signs or symptoms of acute HIV infection on a self-17 |
---|
| 210 | + | reporting checklist of acute HIV infection signs and symptoms; 18 |
---|
| 211 | + | (C) The patient does not report taking any contraindicated medications; 19 |
---|
| 212 | + | (D) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 20 |
---|
| 213 | + | the ongoing use of a preexposure prophylaxis drug. The pharmacist shall notify the patient that the 21 |
---|
| 214 | + | patient shall be seen by a primary care provider to receive subsequent prescriptions for a 22 |
---|
| 215 | + | preexposure prophylaxis drug and that a pharmacist shall not dispense or administer more than a 23 |
---|
| 216 | + | sixty (60) day supply of a preexposure prophylaxis drug to a single patient once every two (2) years 24 |
---|
| 217 | + | without a prescription; 25 |
---|
| 218 | + | (E) The pharmacist documents, to the extent possible, the services provided by the 26 |
---|
| 219 | + | pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 27 |
---|
| 220 | + | The pharmacist shall maintain records of preexposure prophylaxis drugs dispensed or administered 28 |
---|
| 221 | + | to each patient; 29 |
---|
| 222 | + | (F) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 30 |
---|
| 223 | + | preexposure prophylaxis drug to a single patient once every two (2) years, unless otherwise directed 31 |
---|
| 224 | + | by a practitioner; and 32 |
---|
| 225 | + | (G) The pharmacist notifies the patient's primary care provider that the pharmacist 33 |
---|
| 226 | + | completed the requirements specified in this subsection. If the patient does not have a primary care 34 |
---|
229 | | - | LC001940/SUB A/2 - Page 7 of 15 |
---|
230 | | - | network where it can be established that the required services are not available from a provider in 1 |
---|
231 | | - | the health insurer’s network. 2 |
---|
232 | | - | 27-20-80. Expedited Prior Authorization. 3 |
---|
233 | | - | To the extent a prior authorization is permitted and applied, then it shall be conducted in 4 |
---|
234 | | - | an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant § 27-5 |
---|
235 | | - | 18.9-6(a)(1). 6 |
---|
236 | | - | 27-20-81. Dispensing and Administration of HIV PrEP or PEP Drugs. 7 |
---|
237 | | - | (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 8 |
---|
238 | | - | Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 9 |
---|
239 | | - | subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 10 |
---|
240 | | - | PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 11 |
---|
241 | | - | of this section pursuant to a standing order or collaborative practice agreement or to protocols 12 |
---|
242 | | - | developed by the board for when there is no prescription drug order, standing order or collaborative 13 |
---|
243 | | - | practice agreement in accordance with the requirements in this subsection and may also order 14 |
---|
244 | | - | laboratory testing for HIV infection as necessary. 15 |
---|
245 | | - | (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 16 |
---|
246 | | - | training program approved by the board on the use of protocols developed by the board for 17 |
---|
247 | | - | prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 18 |
---|
248 | | - | laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 19 |
---|
249 | | - | to counsel patients prescribed an HIV prevention drug. 20 |
---|
250 | | - | (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 21 |
---|
251 | | - | day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 22 |
---|
252 | | - | (1) The patient tests negative for HIV infection, as documented by a negative HIV test 23 |
---|
253 | | - | result obtained within the previous seven (7) days. If the patient does not provide evidence of a 24 |
---|
254 | | - | negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 25 |
---|
255 | | - | directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 26 |
---|
256 | | - | If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 27 |
---|
257 | | - | direct the patient to a primary care provider and provide a list of primary care providers and clinics 28 |
---|
258 | | - | within a reasonable travel distance of the patient's residence; 29 |
---|
259 | | - | (2) The patient does not report any signs or symptoms of acute HIV infection on a self-30 |
---|
260 | | - | reporting checklist of acute HIV infection signs and symptoms; 31 |
---|
261 | | - | (3) The patient does not report taking any contraindicated medications; 32 |
---|
262 | | - | (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 33 |
---|
263 | | - | the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 34 |
---|
264 | | - | |
---|
265 | | - | |
---|
266 | | - | LC001940/SUB A/2 - Page 8 of 15 |
---|
267 | | - | be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 1 |
---|
268 | | - | that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 2 |
---|
269 | | - | PEP drug to a single patient once every two (2) years without a prescription; 3 |
---|
270 | | - | (5) The pharmacist documents, to the extent possible, the services provided by the 4 |
---|
271 | | - | pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 5 |
---|
272 | | - | The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 6 |
---|
273 | | - | patient; 7 |
---|
274 | | - | (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 8 |
---|
275 | | - | PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 9 |
---|
276 | | - | practitioner; and 10 |
---|
277 | | - | (7) The pharmacist notifies the patient's primary care provider that the pharmacist 11 |
---|
278 | | - | completed the requirements specified in this subsection. If the patient does not have a primary care 12 |
---|
279 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 13 |
---|
280 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 14 |
---|
281 | | - | follow-up care. 15 |
---|
282 | | - | (d) A pharmacist shall dispense or administer a complete course of a post-exposure 16 |
---|
283 | | - | prophylaxis drug as long as all of the following conditions are met: 17 |
---|
284 | | - | (1) The pharmacist screens the patient and determines that the exposure occurred within 18 |
---|
285 | | - | the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 19 |
---|
286 | | - | exposure prophylaxis drug under CDC guidelines; 20 |
---|
287 | | - | (2) The pharmacist provides HIV testing to the patient or determines that the patient is 21 |
---|
288 | | - | willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 22 |
---|
289 | | - | HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 23 |
---|
290 | | - | the pharmacist may dispense or administer a post-exposure prophylaxis drug; 24 |
---|
291 | | - | (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 25 |
---|
292 | | - | the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 26 |
---|
293 | | - | availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 27 |
---|
294 | | - | (4) The pharmacist notifies the patient's primary care provider of the dispensing or 28 |
---|
295 | | - | administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 29 |
---|
296 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 30 |
---|
297 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 31 |
---|
298 | | - | follow-up care. 32 |
---|
299 | | - | (e) The board shall promulgate rules and regulations establishing standards for authorizing 33 |
---|
300 | | - | pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 34 |
---|
301 | | - | |
---|
302 | | - | |
---|
303 | | - | LC001940/SUB A/2 - Page 9 of 15 |
---|
304 | | - | section, including adequate training requirements and protocols for when there is no prescription 1 |
---|
305 | | - | drug order, standing order to collaborative practice agreement. 2 |
---|
306 | | - | SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance 3 |
---|
307 | | - | Organizations" is hereby amended by adding thereto the following sections: 4 |
---|
308 | | - | 27-41-96. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 5 |
---|
309 | | - | prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 6 |
---|
310 | | - | (a) Every group health insurance contract, or every group hospital or medical expense 7 |
---|
311 | | - | insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 8 |
---|
312 | | - | any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 9 |
---|
313 | | - | pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 10 |
---|
314 | | - | (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 11 |
---|
315 | | - | constitute a separate method of administration. A health insurer is not required to cover any 12 |
---|
316 | | - | preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 13 |
---|
317 | | - | out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 14 |
---|
318 | | - | pharmacy benefit. 15 |
---|
319 | | - | (b) The healthcare benefits outlined in this chapter apply only to services delivered within 16 |
---|
320 | | - | the health insurer’s provider network; provided that, all health insurers shall be required to provide 17 |
---|
321 | | - | coverage for those benefits mandated by this chapter outside of the health insurer’s provider 18 |
---|
322 | | - | network where it can be established that the required services are not available from a provider in 19 |
---|
323 | | - | the health insurer’s network. 20 |
---|
324 | | - | 27-41-97. Expedited Prior Authorization. 21 |
---|
325 | | - | To the extent a prior authorization is permitted and applied, then it shall be conducted in 22 |
---|
326 | | - | an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant to § 27-23 |
---|
327 | | - | 18.9-6(a)(1). 24 |
---|
328 | | - | 27-41-98. Dispensing and Administration of HIV PrEP or PEP Drugs. 25 |
---|
329 | | - | (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 26 |
---|
330 | | - | Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 27 |
---|
331 | | - | subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 28 |
---|
332 | | - | PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 29 |
---|
333 | | - | pursuant to a standing order or collaborative practice agreement or to protocols developed by the 30 |
---|
334 | | - | board for when there is no prescription drug order, standing order or collaborative practice 31 |
---|
335 | | - | agreement in accordance with the requirements in this subsection and may also order laboratory 32 |
---|
336 | | - | testing for HIV infection as necessary. 33 |
---|
337 | | - | (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 34 |
---|
338 | | - | |
---|
339 | | - | |
---|
340 | | - | LC001940/SUB A/2 - Page 10 of 15 |
---|
341 | | - | training program approved by the board on the use of protocols developed by the board for 1 |
---|
342 | | - | prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 2 |
---|
343 | | - | laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 3 |
---|
344 | | - | to counsel patients prescribed an HIV prevention drug. 4 |
---|
345 | | - | (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 5 |
---|
346 | | - | day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 6 |
---|
347 | | - | (1) The patient tests negative for HIV infection, as documented by a negative HIV test 7 |
---|
348 | | - | result obtained within the previous seven (7) days. If the patient does not provide evidence of a 8 |
---|
349 | | - | negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 9 |
---|
350 | | - | directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 10 |
---|
351 | | - | If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 11 |
---|
352 | | - | direct the patient to a primary care provider and provide a list of primary care providers and clinics 12 |
---|
353 | | - | within a reasonable travel distance of the patient's residence; 13 |
---|
354 | | - | (2) The patient does not report any signs or symptoms of acute HIV infection on a self-14 |
---|
355 | | - | reporting checklist of acute HIV infection signs and symptoms; 15 |
---|
356 | | - | (3) The patient does not report taking any contraindicated medications; 16 |
---|
357 | | - | (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 17 |
---|
358 | | - | the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 18 |
---|
359 | | - | be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 19 |
---|
360 | | - | that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 20 |
---|
361 | | - | PEP drug to a single patient once every two (2) years without a prescription; 21 |
---|
362 | | - | (5) The pharmacist documents, to the extent possible, the services provided by the 22 |
---|
363 | | - | pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 23 |
---|
364 | | - | The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 24 |
---|
365 | | - | patient; 25 |
---|
366 | | - | (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 26 |
---|
367 | | - | PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 27 |
---|
368 | | - | practitioner; and 28 |
---|
369 | | - | (7) The pharmacist notifies the patient's primary care provider that the pharmacist 29 |
---|
370 | | - | completed the requirements specified in this subsection. If the patient does not have a primary care 30 |
---|
371 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 31 |
---|
372 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 32 |
---|
373 | | - | follow-up care. 33 |
---|
374 | | - | (d) A pharmacist shall dispense or administer a complete course of a post-exposure 34 |
---|
375 | | - | |
---|
376 | | - | |
---|
377 | | - | LC001940/SUB A/2 - Page 11 of 15 |
---|
378 | | - | prophylaxis drug as long as all of the following conditions are met: 1 |
---|
379 | | - | (1) The pharmacist screens the patient and determines that the exposure occurred within 2 |
---|
380 | | - | the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 3 |
---|
381 | | - | exposure prophylaxis drug under CDC guidelines; 4 |
---|
382 | | - | (2) The pharmacist provides HIV testing to the patient or determines that the patient is 5 |
---|
383 | | - | willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 6 |
---|
384 | | - | HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 7 |
---|
385 | | - | the pharmacist may dispense or administer a post-exposure prophylaxis drug; 8 |
---|
386 | | - | (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 9 |
---|
387 | | - | the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 10 |
---|
388 | | - | availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 11 |
---|
389 | | - | (4) The pharmacist notifies the patient's primary care provider of the dispensing or 12 |
---|
390 | | - | administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 13 |
---|
391 | | - | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 14 |
---|
392 | | - | provide the patient a list of physicians, clinics or other health care providers to contact regarding 15 |
---|
393 | | - | follow-up care. 16 |
---|
394 | | - | (e) The board shall promulgate rules and regulations establishing standards for authorizing 17 |
---|
395 | | - | pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 18 |
---|
396 | | - | section, including adequate training requirements and protocols for when there is no prescription 19 |
---|
397 | | - | drug order, standing order or collaborative practice agreement. 20 |
---|
398 | | - | SECTION 5. Section 23-6.3-2 of the General Laws in Chapter 23-6.3 entitled "Prevention 21 |
---|
399 | | - | and Suppression of Contagious Diseases - HIV/AIDS" is hereby amended to read as follows: 22 |
---|
400 | | - | 23-6.3-2. Definitions. 23 |
---|
401 | | - | As used in this chapter the following words shall have the following meanings: 24 |
---|
402 | | - | (1) "Agent" means a person empowered by the patient to assert or waive the confidentiality, 25 |
---|
403 | | - | or to disclose or consent to the disclosure of confidential information, as established by chapter 26 |
---|
404 | | - | 37.3 of title 5, as amended, entitled "Confidentiality of Health Care Communications and 27 |
---|
405 | | - | Information Act." 28 |
---|
406 | | - | (2) "AIDS" means the medical condition known as acquired immune deficiency syndrome, 29 |
---|
407 | | - | caused by infection of an individual by the human immunodeficiency virus (HIV). 30 |
---|
408 | | - | (3) "Anonymous HIV testing" means an HIV test that utilizes a laboratory generated code 31 |
---|
409 | | - | based system, which does not require an individual's name or other identifying information that 32 |
---|
410 | | - | may reveal one's identity, including information related to the individual's health insurance policy, 33 |
---|
411 | | - | to be associated with the test. 34 |
---|
412 | | - | |
---|
413 | | - | |
---|
414 | | - | LC001940/SUB A/2 - Page 12 of 15 |
---|
415 | | - | (4) "Antibody" means a protein produced by the body in response to specific foreign 1 |
---|
416 | | - | substances such as bacteria or viruses. 2 |
---|
417 | | - | (5) "Community-based organization" means an entity that has written authorization from 3 |
---|
418 | | - | the department for HIV counseling, testing and referral services (HIV CTRS). 4 |
---|
419 | | - | (6) "Confidential HIV testing" means an HIV test that requires the individual's name and 5 |
---|
420 | | - | other identifying information including information related to the individual's health insurance 6 |
---|
421 | | - | policy, as appropriate. 7 |
---|
422 | | - | (7) "Consent" means an explicit exchange of information between a person and a healthcare 8 |
---|
423 | | - | provider or qualified professional HIV test counselor through which an informed individual can 9 |
---|
424 | | - | choose whether to undergo HIV testing or decline to do so. Elements of consent shall include 10 |
---|
425 | | - | providing each individual with verbal or written information regarding an explanation of HIV 11 |
---|
426 | | - | infection, a description of interventions that can reduce HIV transmission, the meanings of positive 12 |
---|
427 | | - | and negative test results, the voluntary nature of the HIV testing, an opportunity to ask questions 13 |
---|
428 | | - | and to decline testing. 14 |
---|
429 | | - | (8) "Controlled substance" means a drug, substance, or immediate precursor in schedules 15 |
---|
430 | | - | I-V listed in the provisions of chapter 28 of title 21 entitled, "Uniform Controlled Substances Act." 16 |
---|
431 | | - | (9) "Department" means the Rhode Island department of health. 17 |
---|
432 | | - | (10) "Diagnosis of AIDS" means the most current surveillance case definition for AIDS 18 |
---|
433 | | - | published in the Centers for Disease Control & Prevention (CDC). 19 |
---|
434 | | - | (11) "Diagnosis of HIV" means the most current surveillance case definition for HIV 20 |
---|
435 | | - | infection published in the CDC's (MMWR). 21 |
---|
436 | | - | (12) "Director" means the director of the Rhode Island department of health. 22 |
---|
437 | | - | (13) "ELISA result" means enzyme-linked immunosorbent assay or EIA (enzyme 23 |
---|
438 | | - | immunoassay) which is a serologic technique used in immunology to detect the presence of either 24 |
---|
439 | | - | antibody or antigen. 25 |
---|
440 | | - | (14) "Health benefits" include accident and sickness, including disability or health 26 |
---|
441 | | - | insurance, health benefit plans and/or policies, hospital, health, or medical service plans, or any 27 |
---|
442 | | - | health maintenance organization plan pursuant to title 27 or otherwise. 28 |
---|
443 | | - | (15) "Healthcare facility" means those facilities licensed by the department in accordance 29 |
---|
444 | | - | with the provisions of chapter 17 of this title. 30 |
---|
445 | | - | (16) "Healthcare provider," as used herein, means a licensed physician, physician assistant, 31 |
---|
446 | | - | certified nurse practitioner, pharmacist or midwife. 32 |
---|
447 | | - | (17) "Healthcare settings" means venues offering clinical STD services including, but not 33 |
---|
448 | | - | limited to, hospitals, urgent care clinics, STD clinics and other substance abuse treatment facilities, 34 |
---|
449 | | - | |
---|
450 | | - | |
---|
451 | | - | LC001940/SUB A/2 - Page 13 of 15 |
---|
452 | | - | mental health treatment facilities, community health centers, primary care and OB/GYN physician 1 |
---|
453 | | - | offices, and family planning providers. 2 |
---|
454 | | - | (18) "HIV" means the human immunodeficiency virus, the pathogenic organism 3 |
---|
455 | | - | responsible for HIV infection and/or the acquired immunodeficiency syndrome (AIDS) in humans. 4 |
---|
456 | | - | (19) "HIV CD4 T-lymphocyte test result" means the results of any currently medically 5 |
---|
457 | | - | accepted and/or FDA approved test used to count CD4 T-lymphatic cells in the blood of an HIV-6 |
---|
458 | | - | infected person. 7 |
---|
459 | | - | (20) "HIV counseling" means an interactive process of communication between a person 8 |
---|
460 | | - | and a healthcare provider or qualified professional HIV test counselor during which there is an 9 |
---|
461 | | - | assessment of the person's risks for HIV infection and the provision of counseling to assist the 10 |
---|
462 | | - | person with behavior changes that can reduce risks for acquiring HIV infection. 11 |
---|
463 | | - | (21) "HIV screening" means the conduct of HIV testing among those who do not show 12 |
---|
464 | | - | signs or symptoms of an HIV infection. 13 |
---|
465 | | - | (22) "HIV test" means any currently medically accepted and/or FDA approved test for 14 |
---|
466 | | - | determining HIV infection in humans. 15 |
---|
467 | | - | (23) "Occupational health representative" means a person, within a healthcare facility, 16 |
---|
468 | | - | trained to respond to occupational, particularly blood borne, exposures. 17 |
---|
469 | | - | (24) "Opts out" means that a person who has been notified that a voluntary HIV test will 18 |
---|
470 | | - | be performed, has elected to decline or defer testing. Consent to HIV testing is inferred unless the 19 |
---|
471 | | - | individual declines testing. 20 |
---|
472 | | - | (25) "Perinatal case report for HIV" means the information that is provided to the 21 |
---|
473 | | - | department related to a child aged less than eighteen (18) months born to an HIV-infected mother 22 |
---|
474 | | - | and the child does not meet the criteria for HIV infection or the criteria for "not infected" with HIV 23 |
---|
475 | | - | as defined in the most current surveillance case definition for HIV infection published by the CDC. 24 |
---|
476 | | - | (26) "Person" means any individual, trust or estate, partnership, corporation (including 25 |
---|
477 | | - | associations, joint stock companies), limited liability companies, state, or political subdivision or 26 |
---|
478 | | - | instrumentality of a state. 27 |
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479 | | - | (27) "Persons at high risk for HIV infection" means persons defined as being high risk in 28 |
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480 | | - | the CDC's most current recommendations for HIV testing of adults, adolescents and pregnant 29 |
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481 | | - | women in healthcare settings or through authority and responsibilities conferred on the director by 30 |
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482 | | - | law in protecting the public's health. 31 |
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483 | | - | (28) "Polymerase chain reaction (PCR) test" means a common laboratory method of 32 |
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484 | | - | creating copies of specific fragments of DNA or RNA. 33 |
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485 | | - | (29) "Qualified professional HIV test counselor" means: (i) A physician, physician 34 |
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486 | | - | |
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487 | | - | |
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488 | | - | LC001940/SUB A/2 - Page 14 of 15 |
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489 | | - | assistant, certified nurse practitioner, midwife, or nurse licensed to practice in accordance with 1 |
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490 | | - | applicable state law; (ii) A medical student who is actively matriculating in a medical degree 2 |
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491 | | - | program and who performs duties assigned to them by a physician; or (iii) A person who has 3 |
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492 | | - | completed an HIV counseling training program, in accordance with regulations hereunder 4 |
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493 | | - | promulgated. 5 |
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494 | | - | (30) "Sexually transmitted diseases (STD's)" means those diseases included in § 23-11-1, 6 |
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495 | | - | as amended, entitled "Sexually Transmitted Diseases," and any other sexually transmitted disease 7 |
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496 | | - | that may be required to be reported by the department. 8 |
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497 | | - | SECTION 6. This act shall take effect on January 1, 2024. 9 |
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| 229 | + | LC001940 - Page 7 of 8 |
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| 230 | + | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 1 |
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| 231 | + | provide the patient a list of physicians, clinics or other health care providers to contact regarding 2 |
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| 232 | + | follow-up care. 3 |
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| 233 | + | (iii) A pharmacist shall dispense or administer a complete course of a post-exposure 4 |
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| 234 | + | prophylaxis drug as long as all of the following conditions are met: 5 |
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| 235 | + | (A) The pharmacist screens the patient and determines that the exposure occurred within 6 |
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| 236 | + | the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post-7 |
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| 237 | + | exposure prophylaxis drug under CDC guidelines; 8 |
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| 238 | + | (B) The pharmacist provides HIV testing to the patient or determines that the patient is 9 |
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| 239 | + | willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 10 |
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| 240 | + | HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 11 |
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| 241 | + | the pharmacist may dispense or administer a post-exposure prophylaxis drug; 12 |
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| 242 | + | (C) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 13 |
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| 243 | + | the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 14 |
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| 244 | + | availability of a preexposure prophylaxis drug for persons who are at substantial risk of acquiring 15 |
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| 245 | + | HIV; and 16 |
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| 246 | + | (D) The pharmacist notifies the patient's primary care provider of the dispensing or 17 |
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| 247 | + | administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 18 |
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| 248 | + | provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 19 |
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| 249 | + | provide the patient a list of physicians, clinics or other health care providers to contact regarding 20 |
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| 250 | + | follow-up care. 21 |
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| 251 | + | (c) Rules, regulations and protocols. The board shall promulgate rules and regulations 22 |
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| 252 | + | establishing standards for authorizing pharmacists to prescribe, dispense and administer HIV 23 |
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| 253 | + | prevention drugs in accordance with subsection (b) of this section, including adequate training 24 |
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| 254 | + | requirements and protocols for when there is no prescription drug order, standing order or 25 |
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| 255 | + | collaborative practice agreement. 26 |
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| 256 | + | SECTION 3. This act shall take effect on January 1, 2024. 27 |
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